Events

LAERDAL ADAPTER CABLE, Cat. No. 920650. 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Laerdal Medical Corporation 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    31571
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-0805-05
  • 사례 시작날짜
    2005-04-29
  • 사례 출판 날짜
    2005-05-12
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2008-01-18
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38174
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Dc-Defibrillator, Low-Energy, (Including Paddles) - Product Code LDD
  • 원인
    Incidents of wire breakage in adapter cable resulting in inability to operate the defibrillator.
  • 조치
    Press release issued 4/28/2005. Letters to customers issued 4/29/2005. The letters sent via First Class Mail and are flagged: "URGENT RECALL NOTIFICATION". Customers instructed to order alternative electrode/cable solutions from Philips Medical Systems; discontinue clinical use of Adapter Cables; discard cables or use them for training purposes only.

Device

LAERDAL ADAPTER CABLE, Cat. No. 920650.
  • 모델명 / 제조번호(시리얼번호)
    all lots
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide and worldwide distribution. Laerdal Wappingers Falls, NY is only addressing the nationwide distribution. Laerdal Medical Corp. HQ in Norway is addressing worldwide distribution.
  • 제품 설명
    LAERDAL ADAPTER CABLE, Cat. No. 920650. The cables allow the use of the Laerdal HeartStart multifunction defibrillator pads to be used with the HeartStart 3000 and 4000 series defibrillators and Philips Medical Systems CodeMaster 100 and XL series defibrillators. The Adapter Cable is supplied to customers as an independent accessory and is sold in a clear poly bag with a white stick on label that reads ''PART # 920650 ADAPTER CM100 / LMC ELECTRODE''. There is no other labeling and no directions for use that accompany the product. The Adapter Cable is also included as a component of the CodeMaster 100 Accessory Pack.
  • Manufacturer
    Laerdal Medical Corporation

Manufacturer

Laerdal Medical Corporation
  • 제조사 주소
    Laerdal Medical Corporation, 167 Myers Corner Rd, PO Box 1840, Wappingers Falls NY 12590-8840
  • Source
    USFDA